HIV HOME TEST SELLER LOOKING AT CANADA
By Adnews Staff
An American company which has named itself after its toll-free order line is prepared to sell a mail-order HIV saliva test in Canada, even though federal health authorities have not yet approved the test in either the United States or Canada. At a price of $90 for a set of two, the tests are designed for people afraid of blood tests and for those who want the convenience and privacy of testing at home. The company, 1-888-444-TEST, is seeking approval for the test in both the U.S. and Canada. It is not yet allowed to sell the test in the U.S. However, it can send kits to any Canadians who ask for them. "Regulations permit the importation of certain medical devices for personal use without approval," company president Andy McNabb told Adnews yesterday. McNabb said that since the test has not yet been approved by federal regulators, his company is not even permitted to tell Canadians how they can go about sending in orders. Nevertheless, the company issued a press release this week that says Canadians can call the toll free number to import the kits into Canada. So far, says the company, the test has been proven in 4,000 clinical trials in 22 countries where the product is now being sold. If the saliva test proves positive, it must be confirmed by a blood test.